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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Manipulator/Injector, Uterine
510(k) Number K142164
Device Name MANIPULATOR; MANIPULATOR PRO
Applicant
Gynetech Pty. , Ltd.
229 Marvilla Circle
Pacifica,  CA  94044
Applicant Contact KEVIN MACDONALD
Correspondent
Gynetech Pty. , Ltd.
229 Marvilla Circle
Pacifica,  CA  94044
Correspondent Contact KEVIN MACDONALD
Regulation Number884.4530
Classification Product Code
LKF  
Date Received08/06/2014
Decision Date 12/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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